Spots Global Cancer Trial Database for Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
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Trial Identification
Brief Title: Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
Official Title: Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim Multiple Doses in Patients With Recurrent/Refractory В-cell, CD20-positive Non-Hodgkin Lymphoma of Low Tumor Grade or With Follicular Lymphoma
Study ID: NCT03057418
Interventions
Study Description
Brief Summary: This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade. The study will be carried out in 4-6 Russian and Belarussian sites. The study will be consisted of screening period, induction (obligatory) phase and supporting (non-obligatory) phase of the investigational therapy and post-treatment follow-up period.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
State Budgetary Public Healthcare Institution of the Nizhni Novgorod Region "Hospital of Ambulance of Dzerzhinsk city", Dzerzhinsk, , Russian Federation
Federal State Budgetary Institution "National Medical-Surgical Center n.a. N.I.Pirogov" of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N.Blokhin" of the Russian Academy of Medical Sciences, Moscow, , Russian Federation
Contact Details
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